NCT02001337

Brief Summary

The purpose of this study is to create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and then screen this cohort for pancreatic cancer

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 22, 2013

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 4, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2016

Completed
Last Updated

November 7, 2019

Status Verified

November 1, 2019

Enrollment Period

3.6 years

First QC Date

November 22, 2013

Last Update Submit

November 5, 2019

Conditions

Keywords

pancreatic cancernew-onset diabeticdiabetes

Outcome Measures

Primary Outcomes (1)

  • To create a prospective cohort of subjects with increased probability of being diagnosed with pancreatic cancer and identify pancreatic cancer in this cohort.

    We will prospectively identify patients with newly diagnosed diabetes and perform pancreatic imaging to identify pancreatic cancer

    Follow subjects for 2 years.

Interventions

baseline, quarterly follow-up for 24 months

baseline

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Suspected or definite new-onset diabetes

Patient Characteristics: --Suspected or definite new-onset diabetes based on recent blood sugar and hemoglobin A1c values * No acute illness or steroid therapy * No prior pancreas surgery

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

60ml of whole blood. 5ml urine sample for pregancy testing (if necessary). Stool and saliva samples may be collected.

MeSH Terms

Conditions

Diabetes MellitusPancreatic Neoplasms

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesDigestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Gloria Petersen, PhD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 22, 2013

First Posted

December 4, 2013

Study Start

May 1, 2013

Primary Completion

November 30, 2016

Study Completion

November 30, 2016

Last Updated

November 7, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations